The objective of this study is to provide an ongoing evaluation of clinical outcomes associated with the GORE Flow Reversal System and the GORE Embolic Filter when used for embolic protection during carotid artery stenting.

Evaluate the Major Adverse Event(MAE) rate with the commercial GORE Flow Reversal System and GORE Embolic FIlter through comparison with a performance goal MAE rate based on results from the Gore EMPiRE Clinical Study and the Gore EMBOLDEN Clinical Study [ Time Frame: Treatment through 30 day visit window ] [ Designated as safety issue: Yes ]

Embolic protection by the GORE Flow Reversal System or the GORE Embolic Filter during carotid artery angioplasty and stenting

Other Names:

Neuro Protection System

GORE Neuro Protection System

Parodi

NPS

FRS

PAES

proximal protection

embolic filter

Detailed Description:

Physicians will have the opportunity to select which embolic protection device, the GORE Flow Reversal System or the GORE Embolic Filter, to use during the carotid artery stenting procedure.

This study is not designed to compare study endpoints between the two treatment arms.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patient, or patient's legal representative, is able and willing to provide informed consent.

Patient must be at least 18 years of age or older.

Patient will be selected and treated according to the GORE Flow Reversal System Instructions for Use (IFU) or the GORE Embolic Filter IFU.

Exclusion Criteria:

Patient is contraindicated for the embolic protection device arm they are selected by the investigator to receive: Either Per the GORE Flow Reversal System IFU if the GORE Flow Reversal System is selected OR Per the GORE Embolic Filter IFU if the GORE Embolic Filter is selected

If the patient is contraindicated for both arms (devices) they may not be enrolled.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01343667